A Phase 2 Study to Evaluate Therapies for Inflammatory Bowel Disease

In plain English

What this trial is testing

This study is testing MT-501 (a drug) and MT-201 (a drug) as a possible treatment. Condition(s) listed: Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC) and Crohn's Disease.

It is single-blind: participants do not know which group they are in.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

• Ages 18 to 80
• Any sex

Some of the main requirements, copied from the record:

• Diagnosis of Crohn's Disease (CD), as confirmed by endoscopy and histopathology
• Moderately to severely active CD as defined by Clinical Disease Activity Index (CDAI) and Simple Endoscopic Score (SES-CD)
• Meets drug stabilization requirements

Plus 3 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 140 participants are expected to take part.
• Start date: 2025-06-26.
• Main results expected around 2027-04-30 (estimate from the record).
• 66 study sites listed (66 marked recruiting) in Canada, Georgia, Moldova, Ukraine and United States.

Main thing being measured

• Assess the proportion of participants reporting treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal… (Up to 13 weeks)

In the researchers’ words

This is a Phase 2, multicenter, platform study in adult participants with IBD (moderately to severely active Crohn's Disease or Ulcerative Colitis). The primary goal of this study is to assess the safety and efficacy of multiple investigational drugs.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.